NCT03880760

The Effect of Probiotics on Type 1 Diabetes Mellitus in Children

Completed NA Last updated 4 August 2021

What this trial tests

NA trial testing L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 in Type 1 Diabetes Mellitus in 64 participants. Completed in 31 January 2021.

Timeline

1 August 2018

Primary endpoint
31 October 2020

31 January 2021

Quick facts

Lead sponsor	China Medical University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	1 August 2018
Primary completion	31 October 2020
Estimated completion	31 January 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32
• Placebo

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

China Medical University Hospital

Who can join

Adults 6 to 18, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, investigators try to administer probiotics (Lactobacillus salivarius + Lactobacillus johnsonii + Bifidobacterium lactis from glac biotech Co., Ltd.) to children T1DM patients for 6 months to observe if the inhibition effect of T1DM animal model could be discerned in a short-term period from both change of serum cytokines and beta cells insulin secretion ability.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota in the pathogenesis and therapeutic approaches of diabetes.
   Crudele L, Gadaleta RM, Cariello M, Moschetta A. · · 2023 · cited 147× · PMID 37804567 · DOI 10.1016/j.ebiom.2023.104821
2. Adjuvant Probiotics of <i>Lactobacillus salivarius</i> subsp. <i>salicinius</i> AP-32, <i>L. johnsonii</i> MH-68, and <i>Bifidobacterium animalis</i> subsp. <i>lactis</i> CP-9 Attenuate Glycemic Levels and Inflammatory Cytokines in Patients With Type 1 Diabetes Mellitus.
   Wang CH, Yen HR, Lu WL, Ho HH, et al · · 2022 · cited 68× · PMID 35299968 · DOI 10.3389/fendo.2022.754401
3. Intestinal Dysbiosis in, and Enteral Bacterial Therapies for, Systemic Autoimmune Diseases.
   Marietta E, Mangalam AK, Taneja V, Murray JA. · · 2020 · cited 23× · PMID 33193357 · DOI 10.3389/fimmu.2020.573079
4. Dysbiosis in the Development of Type I Diabetes and Associated Complications: From Mechanisms to Targeted Gut Microbes Manipulation Therapies.
   Gradisteanu Pircalabioru G, Corcionivoschi N, Gundogdu O, Chifiriuc MC, et al · · 2021 · cited 18× · PMID 33803255 · DOI 10.3390/ijms22052763
5. A Triple Threat? The Role of Diet, Nutrition, and the Microbiota in T1D Pathogenesis.
   Hamilton-Williams EE, Lorca GL, Norris JM, Dunne JL. · · 2021 · cited 12× · PMID 33869260 · DOI 10.3389/fnut.2021.600756
6. Intestinal flora: a potential pathogenesis mechanism and treatment strategy for type 1 diabetes mellitus.
   Huang S, Li F, Quan C, Jin D. · · 2024 · cited 8× · PMID 39520706 · DOI 10.1080/19490976.2024.2423024
7. Interaction Between Microbiota and Immunity: Molecular Mechanisms, Biological Functions, Diseases, and New Therapeutic Opportunities.
   Zeng J, He Z, Wang G, Ma Y, et al · · 2025 · cited 5× · PMID 40547945 · DOI 10.1002/mco2.70265